MODIFICATION
R -- Central Institutional Review Board (CIRB) Initiative - Solicitation 1
- Notice Date
- 5/8/2014
- Notice Type
- Modification/Amendment
- NAICS
- 541611
— Administrative Management and General Management Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- N02CM41001-46
- Response Due
- 6/9/2014 4:00:00 PM
- Archive Date
- 6/24/2014
- Point of Contact
- Christopher T. Scott, Phone: 240-276-5427, Lisa Hill, Phone: 240-276-5418
- E-Mail Address
-
scottc2@mail.nih.gov, hilll1@nih.gov
(scottc2@mail.nih.gov, hilll1@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- ATTACHMENTS RFP UPDATED 5/8/14 - SOLICITATION IS NOW POSTED. PLEASE SEE THE ATTACHMENTS. THANK YOU. THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL BE ISSUED ON A LATER DATE. Title: Central Institutional Review Board Support Services (CIRB) The NCI is one of the world's largest public sponsors of clinical trials in cancer, supporting a broad range of prevention, diagnostic, imaging, and treatment studies of new drugs, procedures and multi-modality approaches for oncology patients. Developmental work for new treatments (Phase 1 and 2 trials) has traditionally been carried out in a limited number of institutions while definitive studies comparing new treatments to the standard of care (Phase 3 trials) have required multi-center collaborations. The NCI, through its Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD) and other Divisions/Programs (e.g. Division of Cancer Prevention, Cancer Centers Program), supports multiple sites and investigators in North America to collaborate in multi-center trials/studies (e.g. NCI Cooperative Groups Clinical Trials Program for treatment and radiology imaging, Specialized Programs of Research Excellence (SPORES), Community Clinical Oncology Programs (CCOPs), Minority-Based Community Clinical Oncology Programs (MB-CCOPs), Comprehensive/Clinical Cancer Centers Program, and CTEP Phase 1 and 2 Programs). These NCI multi-center programs each maintain the necessary infrastructure (e.g., scientific committees, statisticians, data managers and quality control monitors) needed to successfully perform clinical trials/studies. The Central Institutional Review Board (CIRB) Initiative is a project of the National Cancer Institute (NCI) to develop and implement a centralized model of IRB review for multi-site, NCI-sponsored clinical trials. The goal of the Initiative is two-fold: A. To streamline regulatory compliance and decrease the duplicative burden of protocol review that currently occurs at hundreds of local IRBs nationwide by providing a single, centralized review that can be utilized by local IRBs participating in NCI-sponsored multi-center trials. B. To maintain and enhance the protection of research participants by providing consistent, expert IRB review at the national level. Currently, the Initiative involves three CIRBs, the Adult CIRB - Late Phase Emphasis reviewing adult NCI-sponsored primarily Phase 3 treatment trials, the Adult CIRB - Early Phase Emphasis reviewing adult NCI-sponsored Phase 0, 1, 2 treatment trials and the PedCIRB reviewing NCI-sponsored pediatric Phase 0, 1, 2, 3, and pilot treatment trials. A fourth CIRB will be established to support DCP trials. The CIRB uses an independent model of IRB review where a local institution and principal investigators inform the CIRB about local context considerations, including local laws and requirements, via the submission of annual worksheets. Each CIRB reviews the NCI-sponsored trials within their purview and additionally review the local context considerations for each institution with investigators credentialed to participate in those trials.This work is currently being conducted under contract HHSN261200800010C held by Emmes, Inc. The NCI seeks continuation of services to be acquired through full and open competitive procedures under NAICS 541611. It is anticipated that a cost-reimbursement, completion-type contract with a base period of six months and nine six month option periods may be awarded beginning on or about August 20, 2014. The RFP will be available electronically at a later date and may be accessed through the FedBizOpps at www.fbo.gov. WE ENCOURAGE ALL RESPONSIBLE SOURCES, PARTICULARLY SMALL BUSINESSES, TO SUBMIT A PROPOSAL WHICH WILL BE CONSIDERED BY THE AGENCY. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile or email transmissions will be accepted. IT IS THE OFFERORS RESPONSIBILITY TO MONITOR THE ABOVE MENTIONED SITE FOR THE RELEASE OF THE SOLICITATION AND ANY AMENDMENTS. Contracting Office Address: 9609 Medical Center Drive Bethesda, Maryland 20852 Primary Point of Contact: Christopher T. Scott Contracting Officer Scottc2@mail.nih.gov Phone: 240-276-5427 Secondary Point of Contact: Lisa Hill Contracting Officer lisa.hill@nih.gov Phone: 240-276-5418
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/N02CM41001-46/listing.html)
- Record
- SN03361364-W 20140510/140509022111-0632b6cc0e723f3d8df00f93dfa02f3d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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